This invention relates to the production of aseptic connectors for connecting in a sterile manner conduits or tubes extending between two bodies, one body and a container, two containers, or otherwise to create an aseptic juncture therebetween for the flow of sterile fluid through said connectors which, essentially, comprise an aseptic connector assembly.
Aseptic connectors and assemblies thereof are well-known. A variety of different designs have been developed heretofore in attempts to assure that when the connectors are used for the aseptic transfer of sterile fluids or the like, such fluids will remain sterile and aseptic. Heretofore, a popular approach has been to utilize membranes penetrated by a piercing point on a prong or spike on the end of a tube which is to receive the fluid. Usually, the membrane is in the form of a flexible sleeve closed at one end and inerted over the prong or spike, needle or otherwise. One example of this type of device comprises the subject matter of prior U.S. Pat. No. 2,689,562 to Adams et al, dated Sept. 21, 1954. One problem inherent to such type of device is that if the spike is used to penetrate receiving membrane and becomes contaminated before the membrane is broken, the spike may contaminate fluid passing through a connector and, in various situations, slidably removable caps placed over spikes or needles heretofore have not proved adequate to maintain the spikes in an aseptic condition since such caps may easily be accidentally or intentionally removed by personnel prior to the time for the connectors to be used, with contamination of the spike possibly resulting.
More recent means to effect connection between two tubes or conduits for sterile fluid comprises the subject matter of U.S. Pat. No. 4,019,512, dated Apr. 26, 1977, and U.S. Pat. No. 4,022,205, dated May 10, 1977, both in the name of Tenczar. The first of these patents is quite complex and includes a pair of telescopic socket members respectively having abutting surfaces at the open ends which are initially sealed by a pair of pressure-sensitive membranes initially covered by protecting films capable of being laterally removed, and then the socket members continue to move toward each other to cause a piercing means in the socket of one member acting to pierce the membranes which are connected by pressure-sensitive cement. The second of these patents is directed to connecting means which are less complex than the first and include a pair of sockets which initially are covered by a pair of membranes, connectable by a pressure-sensitive cement if desired and covered by protecting, removable membranes and when the first mentioned membranes are placed in abutment, a tubular member axially movable within the sleeve in one of the sockets and terminates in a piercing point, is pushed through the connected membranes to effect communication between the sockets. Various coaxial sleeve means respectively in the two sockets also are movable into overlapping position.
Still another patent, U.S. Pat. No. 4,161,949, to Thanawalla, dated July 24, 1979, is directed to an aspetic connector in which two telescopically-related members initially are covered by membranes and additional telescopical-arranged tubes, coaxial with the walls of the main socket members are moved coaxially to pierce the sealing membranes to effect an aseptic connection between the socket members.
Still another relatively recent, prior U.S. Pat. No. 4,369,781, to Gilson et al, dated Jan. 25, 1983, in a general way shows the use of a tapered connection between male and female members and including a flexible, slotted diaphragm of metal through which one of the telescopic members projects to engage a socket in the other member.
In general, the present invention comprises structure which is substantially more simple and therefore, less expensive to manufacture than the devices illustrated in the aforementioned patents and, simultaneously, provides what is believed to be connection means which are superior to, as well as more simple than the prior art devices referred to above, while providing as high, if not a higher degree of asepticism than the devices previously developed, while simultaneously providing greater ease of operation than at least certain of the prior art devices, details of which are set forth below.